Hyperprolactinaemia Management in Reproductive Services at University Hospital of Coventry and Warwickshire

NCT ID: NCT03569787

Last Updated: 2018-06-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 107 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-25
• Study Completion Date: 2017-12-01

Brief Summary

Hyperprolactinaemia and thyroid disorders can significantly reduce fertility by causing ovulatory dysfunction. There is no evidence to suggest treatment of hyperprolactinaemia in the presence of regular ovulatory menstruation will improve fertility. However, anecdotal observation of practice at UHCW NHS Trust suggested that dopamine agonists are often prescribed irrespective of whether symptoms of hyperprolactinaemia are present.

The aim of the study was to establish the prevalence of hyperprolactinaemia and incidence of subclinical hypothyroidism in patients undergoing subfertility investigations at UHCW NHS Trust. Also, to examine management of patients with hyperprolactinaemia and a normal pituitary MRI scan, and explore the trends in treatment; and finally, to explore how this could improve reproductive services.

107 patients were identified as having a high prolactin reading between January 2014 and January 2017. Hospital records were examined for patient demographics, relevant blood and scan results, medical history, any treatment, and treatment outcomes.

The prevalence of hyperprolactinaemia was 23%. 20.6% of patients had suboptimal thyroid function and were started on levothyroxine. Prolactin levels, and presence of relevant symptoms, only had a partial bearing on whether dopamine agonists were used in those with normal pituitary MRI results (or where no scan was performed). The use of dopamine agonists appeared to correlate with assisted conception and a lower incidence of birth complications (inc. miscarriage, prematurity), though the significance of this was limited by the size of the dataset.

Dopamine agonists often appeared to be used in more complex patients, rather than exclusively those with a higher prolactin reading and/or the presence of related symptomatology. Patients frequently underwent a pituitary MRI scan in the absence of symptoms, contrary to evidence. The findings suggest that less patients should be scanned and less treated with dopamine agonists. A health economics evaluation study would be useful to elucidate the potential cost saving this could represent. It may be better to prioritise optimisation of thyroid function, particularly when noting the similarities in the prevalence of suboptimal thyroid function and that of hyperprolactinaemia.

Conditions

Hyperprolactinemia; Subfertility; Subclinical hypothyroïdism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with hyperprolactinaemia

Patients undergoing subfertility studies with at least one high prolactin reading (\>500mU/L).

MRI Pituitary

Intervention Type: DIAGNOSTIC_TEST

Identification of whether of not patients had had an MRI pituitary following hyperprolactinaemia reading

Interventions

MRI Pituitary

Identification of whether of not patients had had an MRI pituitary following hyperprolactinaemia reading

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Undergoing care through subfertility services at UHCW
• Referred and seen in subfertility services between January 2014 to October 2017
• Identified as having had at least one episode of hyperprolactinaemia within the study period (Jan 2014 to January 2017)

Exclusion Criteria

• Referred outside of study period
• Hyperprolactinaemia reading outside of study period

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Megan Crowe

Coventry, , United Kingdom

Countries

United Kingdom

Other Identifiers

GF0253

Identifier Type: -

Identifier Source: org_study_id